Method of preparation for/and insertion of IUD prepackaged in a tubular inserter

ABSTRACT

A relatively narrow diameter tubular inserter adaptable for use with a wide variety of intrauterine devices, having lateral slots therein for retaining a resilient intrauterine device in an undeformed state during shipment and storage prior to insertion. The intrauterine device is moved to a deformed state within the relatively narrow tube just prior to insertion, and ejected therefrom into its normal expanded state within the uterine cavity, whereupon the tube is withdrawn.

United States Patent Lerner June 17, 1975 54] METHOD OF PREPARATION FOR/AND 3590,816 1/1971 Rosenthal 128/130 3,777,748 12/1913 Abramson 11 l28/l30 INSERTION OF IUD PREPACKAGED IN A TUBULAR INSERTER Inventor: Irwin S. Lerner, Greenwich, Conn.

Assignee: A. H. Robins Company,

Incorporated, Richmond, Va,

Filed: Sept. 10, 1973 Appl. N0.: 395,840

Related US. Application Data Division of Ser. No. 187.373. Oct. 7, l97l, abandoned.

US. Cl. 128/127 Int. Cl. A6ll' 5/46 Field of Search 128/127, 128, l29, 13D,

References Cited UNITED STATES PATENTS 6/1970 Cournut l28/l30 Primary Examiner-Richard A. Gaudet Assislunl E.\'uminer.l. C. McGowan Attorney, Agent. or Firm-Strauch, Nolan, Neale. Nies & Kurz [57] ABSTRACT A relatively narrow diameter tubular inserter adaptable for use with a wide variety of intrauterine devices, having lateral slots therein for retaining a resil ient intrauterine device in an undeformed state during shipment and storage prior to insertion. The intrauterine device is moved to a deformed state within the relatively narrow tube just prior to insertion, and ejected therefrom into its normal expanded state within the uterine cavity, whereupon the tube is withdrawn.

5 Claims, 23 Drawing Figures aassaxsss PATENTEDJUN 1 7 1915 SHEET FIG. 7

PATENTEDJUH 17 ms SEEET FIG. I0

FIG. 9

SHEET PATENTEDJUN 17 I975 FIG 20 F IG. I9

FIG. I8

METHOD OF PREPARATION FOR/AND INSERTION OF IUD PREPACKAGED IN A TUBULAR INSERTER This application is a division of application Ser. No. 187.373 filed Oct. 7, 1971, now abandoned; application Ser. No. 187,373 was abandoned in favor of continuation application Ser. No. 447,262. filed Mar. 1, 1974.

CROSS-REFERENCE TO RELATED APPLICATIONS The present invention is useful as an inserter for intrauterine devices of the type shown. described and claimed in prior co'pending application Ser. No. 775,729, filed Nov. 14, 1968, now U.S. Pat. No. 3.633.574. dated Jan. ll. 1972 and assigned to the same assignee as the instant invention.

The inserter described and claimed herein differs substantially from the intrauterine device inserter shown, described and claimed in my prior co-pending application Ser. No. 87,663 filed Nov. 9, 1970, now US. Pat. No. 3,771,520, dated Nov. 13, 1973.

BACKGROUND OF THE INVENTION 1. Field of the Invention The invention relates to the field of intrauterine contraceptive devices, now popularly known as IUDs" and specifically to a tubular inserter useful for insertion of any one of a wide variety of IUDs.

2. Discussion of the Prior Art Background information concerning female contraceptive agents in general and the distinct advantages of the intrauterine device or IUD over other contraceptive agents is set forth in detail in U.S. Pat. Nos. 3,663,574 and 3.771,.520 identified above.

One of the few remaining factors retarding even more widespread acceptance and use of the IUD as a contraceptive agent is the experience of IUD insertion. The development of satisfactory IUD insertion means, readily adaptable to a wide variety of currently popular IUD's will be an important contribution to the art. Such insertion means must firmly engage the IUD during insertion through the cervical canal and positioning in the fundal region of the uterine cavity, yet be easily disengaged therefrom for withdrawal of the inserter. An inserter should be manipulable by one hand only since the other hand of the person performing the insertion will be employed in moving the uterus from its normal anteflexed position to a state of traction whereby the IUD may be easily inserted; this is accomplished by grasping the cervical anterior lip with a tenaculum and exerting a pulling force.

Preferably, lUDs are dispensed as a prepackaged, sterilized assembly with the IUD in place on the inserter so that upon breaking the sterile seal. the device is immediately ready for insertion. A most popular form of inserter is a relatively narrow diameter tube having a rounded, blunt end which will pass through the cervical canal easily and will not damage or injure the fundus upon contact therewith. Such tubes as currently marketed contain a resilient IUD which is deformed into a narrow elongate shape within the tube so that the assembly is ready for immediate use. Once expulsed from the insertion tube within the uterine cavity, the IUD is supposed to resume its normal, undeformed expanded shape.

Unfortunately, the period of time from packaging to use may be quite extended, and the IUD may lose its resilient nature thereby becoming permanently deformed and unable to spring back into its planned expanded configuration once positioned within the uterine cavity. To date, the only answer to the problem has been to package the IUD and its tubular inserter in unattached fashion. This solution yields two unsatisfactory results. First, unnecessary handling is required to assemble the unit prior to insertion, such handling being inherently time-consuming and potentially destructive of the sterile environment of the IUD and its inserter. Secondly, the handler may put the unit together incorrectly thereby either irretrievably jamming the IUD within its tubular inserter, or injuring the ce rvical canal and uterine cavity in attempting to insert an improperly mounted IUD.

U.S. Pat. No. 3,515,132 issued to Charles A. Mc- Knight recognizes the problem of shelf life deterioration of an IUD packaged in a deformed condition, but provides no solution other than to package the IUD separately from the tubular inserter. The tubular inserter disclosed in the patent includes a lateral port adjacent an internal plunger for frictionally engaging an IUD withdrawal cord during insertion, but the tubular inserter is specifically not designed to enter the uterine cavity, nor does the lateral tube port cooperate in any manner in housing the IUD in a normal, expanded configuration.

In contradistinction, the present invention provides a tubular inserter which is packaged with the IUD housed therein in its normal expanded condition. Immediately prior to insertion, the IUD is easily deformed into a compressed shape within the tube and readily expulsed therefrom into its normal, expanded configuration within the uterine cavity. Thus, prolonged deformation of the IUD is avoided, which considerably lengthens the shelf life of such items.

The inserter of the present invention is adaptable for use with a wide variety of IUDs. For example, it may be used with the type of IUD disclosed in U.S. Pat. No. 3,633,574 with open end IUDs, two of which are known in the art as the T" and the 7; with closed loop IUDs such as the Birnberg bow; and with IUDs having a plurality of extended winglike projections for engaging side walls of the uterine cavity to aid in preventing expulsion of the IUD therefrom. The T-form of IUD is disclosed in US. Pat. No. 3,533,406, issued to Howard J. Tatum, and the Birnberg bow is fully disclosed in U.S. Pat. No. 3,230,953, issued to Charles H. Birnberg.

SUMMARY OF THE INVENTION A principal object of the invention resides in the method of preparing a resilient intrauterine device and its inserter for high fundal positioning of the device in a uterine cavity in which the intrauterine device is partially housed within a tubular inserter in an expanded, substantially undeformed configuration and is subsequently moved into an elongate deformed attitude entirely within the tubular inserter.

The objects further provide a method of placement which includes the foregoing basic pre-packaging and pre-conditioning of the intrauterine device followed by inserting the tubular inserter into a cervical canal and expelling the intrauterine device from the tubular member within a uterine cavity. An additional step of moving the tubular inserter to the fundus of a uterine cavity prior to expulsion of the intrauterine device is disclosed; and further steps of the method comprise introducing a plunger into the tubular inserter behind the intrauterine device housed within the tubular inserter and drawing the tubular inserter over the plunger while maintaining the plunger in a stationary position to expel the intrauterine device from the tubular inserter.

A further object of the invention resides in a method of using a universal tubular inserter prepackaged with an expanded IUD therein wherein minimal handling is required to move the IUD into a deformed condition in the tube prior to insertion and positioning.

Further novel features and other objects of this invention will become apparent from the following detailed description, discussion and the appended claims taken in conjunction with the accompanying drawings.

BRIEF DESCRIPTION OF DRAWINGS Preferred structural embodiments of intrauterine de' vices and inserter combination invention are disclosed in the accompanying drawings in which:

FIG. 1 is an elevational view, partially in section, illustrating a preferred form of the invention;

FIG. 2 is a sectional view taken along lines 2-2 of FIG. 1 and drawn to an enlarged scale;

FIG. 3 is an enlarged, partial sectional view showing mounting of the IUD upon the interior plunger portion of the inserter;

FIG. 4 is an enlarged, fragmentary, sectional view of the insertion end of the tubular inserter;

FIGS. 5 through 8 are sequential views illustrating positioning of an IUD still within the insertion tube in the uterine cavity; retraction of the tube from the IUD and expansion of the IUD within the uterine cavity; withdrawal of the tubular inserter from the cervical canal; and final disposition of an IUD within the uterine cavity including insertion depth confirmation;

FIGS. 9, l0 and 11 are partial sectional side views showing prepackaged; deformed; and expulsed attitudes of a T IUD with the tubular inserter,

FIGS. 12, 13 and 14 are views similar to FIGS. 9, l0 and 11 showing the tubular inserter used with a T IUD;

FIGS. 15, 16 and 17 are views similar to FIGS. 9, and 11 illustrating the invention used with a Birnberg bow IUD;

FIGS. 18, I9 and 20 are views similar to FIGS. 9, 10 and 11 showing the invention used with a multiple laterally winged or spur type of IUD;

FIG, 21 is a view similar to FIG. 13 illustrating an al ternative embodiment of insertion tube used with a 7" IUD;

FIG. 22 is a view similar to FIG. 21 illustrating yet another embodiment of insertion tube and an alternative plunger used with a '7 IUD; and

FIG. 23 is a view similar to FIG. 22 showing a tube and plunger similar to those of FIG. 21 used with a T IUD.

DESCRIPTION OF THE PREFERRED EMBODIMENTS A tubular inserter 10 includes an IUD expelling plunger 12 coaxially mounted therein which may include a handle portion 14 at the lower, terminal end thereof. The upper end of plunger 12 is fashioned into an IUD saddle shaped retention seat 16 and, in a preferred embodiment, is hollow throughout its length to accommodate a withdrawal string 18 of an IUD 20. The front, cervix entry end 22 oftubular inserter I0 is annularly rounded to ease insertion of the device into a cervical canal and uterine cavity (FIG. 4). The rear terminal end of tubular inserter 10 may be fashioned into a flange 24 for grasping by the hand of an operator during insertion and positioning of IUD 20.

As illustrated in FIG. I, a resilient IUD 20 is housed within tubular inserter 10 in its normal, undeformed expanded configuration with lateral winglike members 26 projecting through a pair of laterally offset windows 28 formed one on either side adjacent the front, entry end 22 of tubular inserter 10. With this unique arrangement of parts, the entire unit can be prepackaged in a sterile environment with the IUD properly positioned in the tube 10 to be inserted into a cervical canal and uterine cavity, yet during the time between packaging and readying for use, IUD 20 remains undeformed, thus sig nificantly prolonging the shelf-life of the device.

Immediately prior to insertion, all that need be done is to grasp handle 14 and tube flange 24 in order to move IUD 20 slightly upwardly within tube 10 so that IUD 20 assumes an elongate, deformed configuration as illustrated in FIG. 5. As an assist in this operation, the upper edge of each window 18 is rounded upwardly inwardly (FIG. 4) at 29 so that IUD 20 passes easily into tubular inserter 10. In this mode, IUD 20 is entirely housed within tube I0, the tube being of relatively narrow diameter so as to pass through a cervical canal 30 easily. It should be noted that such insertion preparation consumes a minimal amount of time and avoids any handling of IUD 20 and the adjacent portions of tube 10 so as to maintain the sterile integrity of the entire device.

FIG. 6 depicts expulsion of IUD 20 from tubular inserter l0 whereupon IUD 20 will immediately resume its normal, undeformed expanded configuration, with winglike projections 26 in extended position enabling engagement with the side walls 32 of uterine cavity 34 to aid in preventing expulsion of IUD 20 from the uterus.

The insertion and location methodology just de scribed is necessarily performed without benefit of visual assurance that IUD 20 is properly positioned within uterine cavity 34. Other means must be provided not only to assure proper positioning of IUD 20, but also to minimize the possibility of injury to fundus 36 of uterine cavity 34. To this end, tactile disposition means indicating relative displacement between plunger 12 and tubular inserter I0 is provided so that the operator knows at all times during the insertion process the precise disposition and placement of IUD 20 within uterine cavity 34. In a preferred embodiment (FIGS. 1 and 2) such means include equispaced axially aligned semispherical portions 38 formed as projections along the outer surface of plunger 12, cooperating with a mating set of equispaced, axially aligned detents or recesses 40 formed along the inner surface of tubular inserter 10. Preferably, adjacent pairs of projections 38 and recesses 40 are spaced about 1 cm. apart. As tube 10 is slid downwardly over plunger 12 to expel IUD 20 (FIGS. 5 and 6) a tactile click will be transmitted to the hand of the operator, signalling him that in fact IUD 20 is being properly expelled. Simultaneously, the operator can determine that IUD 20 is placed in the proper plane within the uterus (FIGS. 5-8) in that should any relative rotation occur between tube and plunger 12 during insertion, the tactile click provided by normally axially aligned members 38, 40 will not be felt. In this embodiment, IUD is approximately 21 mm. in length, so that upon sensing two clicks as tube 10 is slid downwardly over plunger 12, the operator will know that IUD 20 has in fact been expelled from tube 10, and that then both tubular inserter 10 with plunger 12 may be withdrawn from the uterus altogether, as illustrated in FIGS. 7 and 8.

The usual practice in the prior art of tubular inserters has been to insert the tube to the internal 0s and then to hold the tube stationary while expelling the IUD therefrom by continued forward motion of the plunger, as disclosed in US. Pat. No. 3,515,132, by way of example. There are at least two distinct disadvantages in this methodology. First, it is extremely difficult to determine the precise location of the internal os, by any reasonable sounding process. Secondly, if the tubular inserter is not properly located, the delicate uterine cavity fundus may be injured or even ruptured by expulsion step, if the tube is inserted too far, or the IUD may be deposited partially or entirely within the cervical canal where it has little chance of accomplishing its intended function. On the other hand, tubular inserter 10 with IUD 20 of the present invention is intended to be inserted all the way to fundus 36 as shown in FIG. 5. Injury to fundus 36 will not occur, due to the annular rounding of tube end 22. Proper depth location for the IUD 20 being placed into the uterus is assured by contact of tube end 22 with fundus 36. By then withdrawing tube 10 over plunger 12, instead of moving plunger 12 upwardly within tube 10 as in the prior art practice, possibility of injury to the uterine cavity is minimized, since movement of the parts is now in a direction away from fundus 36 instead of towards it.

A discussion of the entire IUD insertion process is now in order. First, the vagina of the user is dilated with a speculum followed by cleansing of the cervix (not shown). Then, the exterior os of the cervix is grasped by a tenaculum to draw the uterus from its normal anteflexed position into a state of traction so that the axis of the uterus is generally aligned with the axis of the vagina, to ease insertion of the IUD into the cervical canal and uterine cavity (not shown). A sounder is next employed to measure depth and determine the particular axis and contour of the uterus. Then the IUD itself is inserted and positioned as previously described. Assurance of proper insertion depth may be provided by a series of gradations 42 affixed exteriorally of tubular inserter 10 which indicate the distance from tube end 22 to the point where an individual gradation 42 appears on tubular inserter 10. As is the usual gynecological practice, these measurements are demarcated in centimeters. A final confirmation of proper IUD insertion depth may be provided by a knot 43 located near the lower free end of IUD withdrawal string 18; knot 43 is usually positioned about 7 cm. from the upper end of IUD 20 (FIG. 8).

The present invention is easily adaptable to a wide variety of IUDs, as is illustrated by FIGS. 9 through 21. FIGS. 9, l0 and 11 show a T IUD 44 positioned with the major portion thereof within tubular inserter 10 prior to insertion preparation, deformed to an elongate configuration within tube 10 for insertion into the uterus, and expelled therefrom as by drawing tube 10 down over plunger 12 once IUD 44 is positioned in the uterine cavity. The outer end of seating head 16 of plunger 12 may be bifurcated at 45 to centrally accommodate T IUD 44 at the intersection of its stern cross member.

FIGS. 12, 13 and 14 are similar to FIGS. 9, l0 and 11 but illustrate the invention being used with a 7" IUD 46. Saddle 16 may be placed centrally beneath the cross member of7" IUD 46 (FIG. 12). As plunger 12 is moved upwardly to compress 7" IUD 46 within tube 10 just prior to uterine insertion, lower curved terminal seat 48 of plunger 12 engages the base of the stem of IUD 46 so that the portions of IUD 46 projecting through windows 28 may fold inwardly of the tube 10 as they pass curved window edges 29. When tube 10 is drawn down over plunger 12 to expel IUD 46 within the uterine cavity, IUD 46 assumes its normal, undeformed configuration (FIG. 14).

FIG. 21 illustrates an alternative embodiment of the number and disposition of windows 28 to accommodate a 7" IUD 46 or equivalent structure. Tubular inserter 10 is provided with but one window 28, with sad dle 16 arranged to engage IUD 46 adjacent fillet 50 thereof. Thus, only free end 52 of IUD 46 projects from tubular inserter 10 prior to withdrawal of the IUD into tube 10. As in the embodiment shown in FIGS. 12, 13 and 14, movement of plunger 12 upwardly in tube 10 will retract the projecting portion 52 of IUD 46 into tubular inserter 10.

FIG. 22 discloses an alternative embodiment of a tubular inserter and plunger used with a 7" IUD. Tubular inserter 10 has but one window 28 but comprises internal passage portions 64 and 66 having differing internal diameters but being coaxially aligned. Stem 68 of7" IUD 46 is stored in the lower, smaller diameter passage portion 66. Plunger 12 is solid in this embodiment and has an IUD engaging end 70 which may be slightly concave to assure firm seating of IUD 46 thereon when the plunger is operated. Pushing on the plunger 12 will retract IUD 46 into the upper, larger diameter passage portion 64 of tubular inserter 10 where free end 52 and stem 68 will lie approximately parallel to one another, prior to expulsion of the IUD within the uterus. In a prefered embodiment, the internal diameter of upper portion 64 will be about twice the diameter of the stem of IUD 46 to comfortably accommodate end 52 and stem 68 therewithin. Lower portion 66 has a diameter of about 1.5 times the diameter of IUD 46, since only the stem is received therein. Plunger 12 will have a diameter somewhat smaller than this, so as to slide easily within the tubular inserter and also to provide sufficient space for withdrawal cord 18 to fit therealongside without binding between the inserter and plunger during IUD insertion.

The embodiment disclosed in FIG. 23 comprises a plunger and inserter tube used with a T IUD, similar in structure and function to the plunger and inserter disclosed in FIG. 22 except that upper portion 64 is about 2.5 times the diameter of the T IUD, or more so as to accommodate the stem and both halves of the head of T IUD 44 with minimal distortion being imparted to tubular inserter 10. In the case of both of the embodiments illustrated in FIGS. 22 and 23, the diameter dimensions given are only approximations and the drawings are not necessarily to scale. However, the diameter sizes given yield a satisfactorily operable inserter and plunger.

FIGS. l5, l6 and 17 are similar to FIGS. 9, l and 11 except that a Birnberg bow 54 is shown, and two sets of planarly aligned windows 28 are provided in tubular inserter to house the major portion of IUD 54 prior to insertion preparation. As IUD 54 is expulsed into the uterine cavity by drawing tube 10 downwardly over plunger 12, the lower projecting portions of IUD 54 will rachef past upper windows 28 of tube 10 which provide a further tactile signal to the operator that the IUD expulsion process is proceeding properly.

FIGS. 18, I9 and are similar to FIGS. 9, l0 and 11, illustrating the invention used with an IUD 56 com prising a perimeter 57, central membrane 59, and a plurality of projecting spurs 61 which may be webbed at 63 for better IUD retention once in place within the uterus.

The configuration of plunger 12 with its saddle I6 and lower curved terminal seat 48 is the same for use with inserting any IUD suitable for this invention. Referring to FIG. 3, seat 48 and saddle I6 are interconnected by a long slender curved neck 58. Members 16, 48 and 58 are all gently rounded to minimize the possibility of injury to the walls of the uterus and cervical canal during insertion. Plunger 12 is generally hollow throughout its length and includes an opening 60 formed in seat 48 to allow withdrawal string 18 to be housed within plunger 12 during the insertion process so as not to interfere with relative moving parts of the invention. Preferably, although not necessarily, saddle l6 and lower seat 48 are disposed apart a distance greater than the undeformed length of an IUD mounted thereon (FIG. 3) so during the time the IUD is deformed within tube I0, both saddle I6 and seat 48 en gage upper and lower portions of the IUD respectively, but upon expulsion of the IUD from the tube 10 within the uterus, only saddle I6 need be disengaged, as by rotating the invention a quarter turn (FIG. 6), seat 48 and the IUD becoming disengaged by the return of the IUD being inserted to its normal, undeformed position within the uterus.

The invention may be embodied in other specific forms without departing from the scope, spirit or essential characteristics thereof. The present embodiments are, therefore, to be considered in all respects as illustrative and not restrictive. the scope and spirit of the invention being indicated by the appended claims rather than by the foregoing description, and all changes which come within the meaning and range of equivalency ofthe claims are, therefore, intended to be embraced therein,

What is claimed and desired to be secured by Letters Patent is:

l. A method of preparing a resilient intrauterine device for high fundal positioning in a uterine cavity comprising the steps of: partially housing said intrauterine device in an expanded, substantially undeformed configuration within a tubular inserter. rearwardly of a forward, expulsion end of said inserter; and moving said intrauterine device forwardly, toward the expulsion end of said inserter, into an elongate deformed attitude entirely within the tubular inserter.

2. The method of claim 1 wherein the intrauterine device is positioned within a uterus by the further steps of inserting the tubular inserter into a cervical canal; and expelling the intrauterine device from the tubular member within a uterine cavity.

3. The method of claim 2 wherein the step of inserting the tubular inserter into a cervical canal includes the step of moving the tubular inserter to the fundus of a uterine cavity prior to expulsion of the intrauterine device.

4. The method of claim 3 wherein the step of expelling the intrauterine device from the tubular inserter includes the further steps of: introducing a plunger into the tubular inserter behind the intrauterine device housed within the tubular inserter; and drawing the tubular inserter over the plunger while the plunger is in a stationary position to expel the intrauterine device from the tubular inserter.

S. The method of claim wherein said steps of partially housing an intrauterine device within a tubular inserter and moving said intrauterine device into an elongate deformed attitude within said tubular inserter are completed prior to insertion of said tubular inserter into a cervical canal. 

1. A method of preparing a resilient intrauterine device for high fundal positioning in a uterine cavity comprising the steps of: partially housing said intrauterine device in an expanded, substantially undeformed configuration within a tubular inserter, rearwardly of a forward, expulsion end of said inserter; and moving said intrauterine device forwardly, toward the expulsion end of said inserter, into an elongate deformed attitude entirely within the tubular inserter.
 2. The method of claim 1 wherein the intrauterine device is positioned within a uterus by the further steps of inserting the tubular inserter into a cervical canal; and expelling the intrauterine device from the tubular member within a uterine cavity.
 3. The method of claim 2 wherein the step of inserting the tubular inserter into a cervical canal includes the step of moving the tubular inserter to the fundus of a uterine cavity prior to expulsion of the intrauterine device.
 4. The method of claim 3 wherein the step of expelling the intrauterine device from the tubular inserter includes the further steps of: introducing a plunger into the tubular inserter behind the intrauterine device housed within the tubular inserter; and drawing the tubular inserter over the plunger while the plunger is in a stationary position to expel the intrauterine device from the tubular inserter.
 5. The method of claim 1 wherein said steps of partially housing an intrauterine device within a tubular inserter and moving said intrauterine device into an elongate deformed attitude within said tubular inserter are completed prior to insertion of said tubular inserter into a cervical canal. 